Device for supporting a user&#39;s body

ABSTRACT

The invention provides a variety of devices for supporting at least a portion of a user&#39;s body. In some embodiments, the invention provides a support device which includes a bladder capable of containing a fluid and a post adjacent the bladder. The bladder may form a rolling diaphragm portion with the post such that when a force is applied to the bladder, the rolling diaphragm portion of the bladder rolls along the post decreasing the volume of the bladder. In some embodiments, the invention provides a post which includes a reduced cross-sectional area in comparison to an adjacent region of the post such that the resistance of the rolling diaphragm portion of the bladder to rolling movement along the post due to the applies force decreases as the bladder rolls along the reduced cross-sectional area region. In some embodiments, the support device includes a plurality of bladders and/or a plurality of posts.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/012,606, filed Aug. 28, 2013, which is a continuation of U.S.application Ser. No. 12/448,027, filed Feb. 22, 2010, and issued as U.S.Pat. No. 8,572,783 on Nov. 5, 2013, which is a national stage ofInternational Application Serial No. PCT/US2007/025132, filed Dec. 7,2007, which is hereby incorporated by reference in its entirety.International Application Serial No. PCT/US2007/025132 claims thebenefit under 35 U.S.C. §119(e) of U.S. Provisional Application Ser. No.60/873,742, filed Dec. 9, 2006 and U.S. Provisional Application Ser. No.60/909,655, filed Apr. 2, 2007.

FIELD OF THE INVENTION

The present invention relates generally to devices for providing supportto at least a portion of a user's body, and in particular to a devicewhich may adjust the pressure on certain portions of the user's body.

BACKGROUND OF THE INVENTION

Various types of support devices, such as mattresses, cushions, chairs,are known to support a user's body. A conventional mattress may includean array of spring elements to support a body. When a user lays on aconventional mattress, the springs compress. As the level of compressionincreases, the resistive force in the springs increase as a result ofuser's weight on the mattress. This increased resistance tends to focuson protruding regions of patient anatomy which may cause lesions such aspressure ulcers, or other local circulatory problems, especially inbedridden patients. Protuberant regions of the anatomy are more prone todevelop pressure sores because they tend to penetrate more deeply intomattresses, encountering greater forces than nearby regions and thus aremore likely to have diminished local blood circulation.

Areas of a patient's body exposed to higher pressures when positioned ona support device, i.e., pressure points, are undesirable. Currentmethods to reduce pressure points on bedridden patients involvefrequently moving or rotating the position of the patient on the supportdevice so that a pressure point does not lead to the above-mentionedlesions. While this approach may be helpful, it requires someone, suchas a nurse, to physically move the patient. This is time consuming andmay also lead to injuring the nurse and/or the patient.

SUMMARY OF INVENTION

Aspects of the present invention are directed to a support device whichhelps to minimize pressure points on a user's body when the user issupported by the device. By minimizing the pressure points on a user'sbody, aspects of the present invention are directed to reducing theincidence of pressure ulcers and local circulatory problems.

Certain embodiments of the present invention are directed to providing asupport to device with a low interface pressure. By providing a lowinterface pressure, the certain embodiments of the present invention mayreduce the need to move and/or rotate a bedridden patient as frequently.

In one embodiment, a device is provided for supporting at least aportion of a user's body. The device includes a bladder capable ofcontaining a fluid, and a post adjacent the bladder. The bladder forms arolling diaphragm portion with the post such that when a force isapplied to the bladder, the rolling diaphragm portion of the bladderrolls along the post, decreasing the volume of the bladder.

In certain embodiments, the invention provides a support device with theabove described bladder and post where the cross-sectional area of thepost varies along its length. As set forth in greater detail below,altering the cross-sectional area of the post can alter the amount ofresistance of the bladder to the rolling movement along the post. In oneembodiment, the post includes at least one region having a reducedcross-sectional area in comparison to an adjacent region of the postsuch that the resistance of the rolling diaphragm portion of the bladderto rolling movement along the post due to the applied force decreases asthe bladder rolls along the at least one region having the reducedcross-sectional area.

In certain embodiments, the invention provides support device forsupporting at least a portion of a user's body. The support deviceincludes a plurality of bladders capable of containing a fluid, wherethe plurality of bladders includes at least a first bladder and a secondbladder. The support device further includes a plurality of postsadjacent to and supporting the plurality of bladders, such that at leastone post is positioned adjacent to and supports each of the plurality ofbladders. The plurality of posts include at least a first post and asecond post, with the first post positioned adjacent to and supportingthe first bladder and the second post positioned adjacent to andsupporting the second bladder. The first and second bladders each formsa rolling diaphragm portion with the first and second posts,respectively, such that when a force is applied to the first bladder,the rolling diaphragm portion of the first bladder rolls along the firstpost decreasing the volume of the first bladder, and when a force isapplied to the second bladder, the rolling diaphragm portion of thesecond bladder rolls along the second post decreasing the volume of thesecond bladder.

In certain embodiments, the invention provides a device for supportingat least a to portion of a user's body. The device includes at least onebladder capable of containing a fluid, and a plurality of posts adjacentthe at least one bladder. The plurality of posts includes at least afirst post and a second post. At least a portion of the at least onebladder forms a first and second rolling diaphragm portion with thefirst and second posts, respectively, such that when a force is appliedto the at least one bladder at a location adjacent the first post, thefirst rolling diaphragm portion of the at least one bladder rolls alongthe first post decreasing the volume of the at least one bladder, andwhen a force is applied to the at least one bladder at a locationadjacent the second post, the second rolling diaphragm of the at leastone bladder rolls along the second post decreasing the volume of the atleast one bladder.

BRIEF DESCRIPTION OF DRAWINGS

The accompanying drawings are schematic and are not intended to be drawnto scale. In the figures, each identical, or substantially similarcomponent that is illustrated in various figures is typicallyrepresented by a single numeral or notation. For purposes of clarity,not every component is labeled in every figure, nor is every componentof each embodiment of the invention shown where illustration is notnecessary to allow those of ordinary skill in the art to understand theinvention. In the drawings:

FIGS. 1A-1C are schematic cross-sectional illustrations of a supportdevice according to one embodiment;

FIGS. 2A-2B are schematic cross-sectional illustrations of two postshaving different cross-sectional areas.

FIGS. 3A-3B are schematic cross-sectional illustrations of a supportdevice in a first position and a second position according to anotherembodiment;

FIGS. 4A-4C are schematic illustrations of three differently shapedposts along the stroke axis illustrating the different pressure andreaction force characteristics associated with the different posts;

FIGS. 5A-5C are schematic illustrations of a support device including ablower for air pressure delivery and a pressure controller;

FIGS. 6A-6B are schematic illustrations of a support device including aplurality of zones according to another embodiment;

FIGS. 7A-7C are schematic illustrations of a support device including aplurality of zones according to another embodiment for use in a hospitalbed with a Personal Digital Assistant;

FIGS. 8A-8B are schematic illustrations of a support device includingperforations for ventilation according to another embodiment;

FIGS. 9a-9h are schematic illustrations of a bladder being coupled to apost according to other embodiments;

FIGS. 10A-10B are schematic illustrations of a disposable patientcontacting surface for the support device according to anotherembodiment;

FIG. 11 is a schematic illustration of a support device according toanother embodiment;

FIG. 12 is a schematic illustration of a support device according to yetanother embodiment;

FIG. 13A is a graph of load vs. deflection for a support device atvarious pressures according to another embodiment;

FIGS. 13B-13C are schematic illustrations of a support device used togenerate the data in FIG. 13A;

FIG. 13D is a graph of Contact Pressure vs. Compression Distance for asupport device at various pressures according to yet another embodiment;and

FIG. 14 is a graph of load vs. deflection for a support device accordingto one embodiment compared to data for a foam mattress and a water bed.

DETAILED DESCRIPTION

The present invention provides a device for supporting a portion of auser's body. It should be appreciated that in some embodiments, thedevice may be part of and/or may form a mattress. In other embodiments,the device may be part of and/or may form a chair, and in yet otherembodiments, the device may be part of and/or may form a cushion orpillow or other support surface/device or portion thereof.

Certain embodiments of the support device include bladders with portionswhich act as a rolling diaphragm. In particular, the support device mayinclude at least one bladder and a post positioned adjacent to andsupporting the bladder. The bladder may to include a rolling diaphragmportion capable of rolling along the post. The rolling diaphragm portionof the bladder may roll along the post in response to a force applied tothe bladder. The position of the bladder with respect to the post canaffect the volume within the bladder. In one embodiment, the volume ofthe bladder decreases and increases as the bladder rolls along the postin a first and second direction of travel, respectively.

The inventive support device will now be described in more completedetail in the context of several specific embodiments illustrated in theappended figures. It is to be understood that the embodiments describedare for illustrative purposes only and that the inventive features ofthe invention, as described in the appended claims, can be practiced inother ways or utilized for instruments having other configurations, asapparent to those of ordinary skill in the art.

Certain embodiments of the present invention are directed to a supportdevice which may include one or more bladders 10 capable of containing afluid. The embodiment illustrated in FIG. 1 depicts a pair of supportdevices 5, each including a fluid-filled bladder 10 with an adjacentpost 14. The dashed region in FIGS. 1B-1C illustrates the fluid withinthe bladders 10.

It should be appreciated that the bladder 10 and posts 14 may be made ofa variety of materials as the invention is not so limited. For example,the bladder 10 may be made from materials such as, but not limited tovarious flexible and substantially fluid impermeable material likerubber and various plastic materials, and the post may be made frommaterials such as plastic materials, metals, wood, etc. withoutlimitation.

In one embodiment, the bladder is constructed of a fabric coated with ormolded to an elastomer. The elastomer may be a natural rubber or asynthetic compound, and may, for example be between approximately 30-90shore D durometer. In one embodiment, the fabric may be a cotton,polyester, polyester, such as polyethylene, or KEVLAR®, obtained fromDuPont. In one embodiment, the thickness of the bladder is betweenapproximately 0.01-0.04 inches. In one particular embodiment, thebladder is made from a non-latex elastomer, such as neoprene, with acotton embedded fabric. The thickness of the bladder material may beapproximately 0.03 inches and the expanded bladder diameter may beapproximately 2 inches.

In one embodiment, the post 14 may be made from ABS (Acrylonitrilebutadiene styrene), polycarbonate, PVC (Polyvinyl chloride), or styrene.As discussed in greater detail below, in some embodiments, the post 14is a rigid structure, whereas in other embodiment, the post 14 is aresilient structure, and may for example be inflatable.

Some of the below-mentioned embodiments utilize air as the fluid withinthe bladder. It is also contemplated that other fluids, including othergases as well as liquids, such as water, may also be employed. It shouldalso be recognized that the fluid may be temperature controlled.

FIG. 1A is a top view of one bladder 10, illustrating one embodimentwith an approximately square upper surface 12. In another embodiment,the bladders 10 may be shaped differently as the present invention isnot limited in this respect. For example, in one embodiment, the bladder10 may be approximately hexagonal and/or approximately round in shaperather than square.

In one embodiment, the upper surface 12, and/or the upper portion of thewalls 16 of the bladder 10, may include a patient-contacting finish orlayer, which may include various types of foam, gel, and/or padding.

FIG. 1B illustrates a cross-section of a bladder 10 and a post 14 onwhich it may be coupled. In this particular embodiment, the side wall 16of the bladder 10 is coupled at region 18 to the post 14 by adhesive orother coupling. In this particular embodiment, the side wall 16 of thebladder 10 passes downward initially, then curves upward in region 34and runs upward to top surface 12 of the bladder. In one embodiment, thepost 14 includes a channel or passage 22 which fluidly connects a fluidduct 24 running through the base region 26 of post 14 with the inside ofthe bladder 10. The base region 26 may be connected to a supportingframe 28. Fluid ducts 24 may be connected by connectors 30 to eachother, or to tubing (not illustrated) to form a support device includinga fluidly connected array of bladders 10 and posts 14.

The support device 5 is typically at a given pressure P (not labeled),which in one embodiment, is the same for all bladders 10 within adevice, or within one or more specific regions or zones of a device 5.As discussed in greater detail below, the posts 14 may be disposed inone or more separately pressure regulated regions or zones, and may alsobe connected to a fluid pressurizing system to fill the bladder withfluid, such as, but not limited to, an air compressor, a fan, a pump forliquid or air, or a liquid reservoir raised to an appropriate heightabove the connectors 30 (not illustrated).

The fluid ducts 24 may be coupled via connectors 30 which are able towithstand the anticipated pressures in the device. In one embodiment,the pressure within the device is between approximately 0.1-1 psig. Inanother embodiment, the pressure within the device may be as much asapproximately 1-10 psig or more. It should be appreciated that a largerpressure may be useful to elevate or move patients. The pressure may beregulated by a pressure regulator of any type, and/or a centrifugalpump, and the system pressure may be variable with time, or zoned, orboth, as described below. Local controls may regulate particular zonesof the device, using conventional electric and fluidic control devices.In another embodiment, posts 14 may be mounted directly into a manifold,and the manifold is fluidically connected to the rest of the device, forexample through valves or regulators.

FIG. 1C illustrates an embodiment similar to the that shown in FIG. 1B,except the bladder 10 has been pushed in a downward direction by anapplied force. In this configuration, the bladder 10 forms a rollingdiaphragm as the bladder wall 16 has rolled down the post 14 untilcurved region 34 has contacted the base 26 of the post 14. As shown, theinterior volume 32 of the bladder shown in FIG. 1C is smaller than theinterior volume 32 of the bladder shown in the configuration shown inFIG. 1B. In this particular embodiment, the fluid lost in pressing downthe top surface 12 of the support device 5 in FIG. 1C exits through thefluid passages 22, fluid ducts 24, and connectors 30. In one embodiment,the fluid passage 22 is approximately 0.06 inches in diameter and isapproximately 1 inch in length. In one particular embodiment, the fluidpassage 22 is formed with a hole axially extending through a fastener,such as a screw.

In one embodiment, the distance the bladder wall 16 is capable ofrolling down the post 14 from its fully extended position (such as FIG.1B), before encountering any region of increased post diameter (e.g.base 26, such as in FIG. 1C), may be at least approximately 50% or moreof the length of the post. In another embodiment, the bladder wall 16 iscapable of traveling along at least approximately 70% or more of thelength of the post, and in yet another embodiment, the bladder wall 16is capable of traveling at least approximately 80% or more of the lengthof the post.

As illustrated in FIGS. 1B-1C, in one embodiment, a plurality ofbladders 10 may be fluidically interconnected so that the pressurewithin a first bladder is capable of reaching an equilibrium with thefluid pressure within a second bladder. In one illustrative embodiment,the fluid duct 24 and fluid passage 22 extending through the posts 14fluidly connects the first and second bladders 10. It should beappreciated that in other embodiments, the fluid pressure within thefirst bladder may be capable of reaching an equilibrium with the fluidpressure within a second bladder 10 through various types ofconventional sensors as the invention is not so limited.

Turning now to the schematic illustrations shown in FIGS. 2A and 2B, themechanistic basis for one embodiment of the support device according tothe present invention is more fully described. To better enable theunderstanding of the support devices, a simple mechanical analogy isshown in cross section in FIGS. 2A-2B. In FIG. 2A, a piston 110, havinga diameter D 1 and a top surface 112, passes through a sealing ring 114into a cylinder 116 having a side wall 118, a top surface 120 and an airoutlet 122.

If the cylinder 116 is supplied with air at pressure P, then to preventthe piston from moving, a certain force, F1, will be required to preventthe piston 110 from being forced out of the cylinder by pressure P. Therequired force will be proportional to the cross-sectional area of thepiston 110 where the piston passes through the sealing ring 114. If thepiston is cylindrical in shape, the required force will be proportionalto the square of the diameter D1 of the piston 110 where it passesthrough the sealing ring 114 into the cylinder 116. If the actual forceapplied is greater than F1, the piston will enter the cylinder, andunless pressure P is increased, the piston will eventually reach the top120 of the cylinder 116.

FIG. 2B is similar to FIG. 2A except that piston 111 has a smallerdiameter, D2, with an upper end 113, and going through a smaller sealingring 115. A smaller force, F2, proportional to the square of thediameter D2 of the portion of the piston passing through the seal 113,will be required to maintain the piston 111 in place, or to force itinto the cylinder 118. Note that the appropriate place to measure thediameter to determine the force to prevent motion is at the seal, andnot at the inward ends 112, 113. For example, one could place a thinplate on end 113 of FIG. 2B that was as big as that of end 112 of FIG.2A, and as long as the plate did not make sealing contact with the wallsof the cylinders 118, it would make no difference to the force requiredto balance the respective pistons 110, 111 against pressure P.

FIGS. 2A-2B are similar to FIGS. 1B-1C, with the cylinder 118 analogousto bladder 10 and pistons 110 or 111 analogous to post 14. In oneembodiment, instead of a sliding seal 114 or 115 and motion of a pistonthrough it, the curved region 34 of the bladder 10 acts as a rollingdiaphragm moves up and down with respect to the top surface 20 of thepost 14. The diameter and geometry of post 14 may be selected to controlthe critical intra-bladder pressure Pc, below which critical pressure agiven weight will start to depress the upper surface of a bladder 10.

In one embodiment, the resistance of the bladder 10 to the rollingmovement along the post 14 due to an applied force may decrease as thebladder 10 moves along certain regions of the post. As shown in FIGS. 3aand 3b , in one embodiment, a support device is provided where theresistance of the bladder to losing volume decreases as the top surface146 of the bladder is pressed downwards. In other words, as a personsinks part of their anatomy into the support device, such as a mattress,and pushes below the surface, the reaction force or upward pressure isreduced as deflection is increased. This is in sharp contrast to typicalsupport devices, such as s spring mattress, where as the deflection isincreased, the force of resistance of the spring would increase. Thisdecreasing resistance behavior can be measured with exemplary data beingprovided below.

In one embodiment, this is accomplished by including a post 162 with areduced cross-sectional area in comparison to an adjacent region of thepost 162. In the embodiment illustrated in FIGS. 3A-3B, the post's outerdiameter tapers, either smoothly or abruptly at a defined depth oftravel from the top surface. In FIG. 3A, the post 162 has an upperregion 160 with a larger diameter and a lower region 166 of reducedouter diameter, with a transition region 168 having a varying diameterin between. The bladder 142 has top surface 146, a seal 144, and may begenerally similar to the bladders of previous embodiments. The post 162,includes a fluid flow lumen 150 in fluid communication with a connector152 With no weight or force applied, and when inflated by a positivesystem pressure, the bladder 142 will have a chamber 148 inflated to itsmaximum volume.

FIG. 3B illustrates the effects of applying weight above the criticalpressure to the support of FIG. 3A. As such a weight is applied to topsurface 146, the bladder 142 is compressed and the volume of chamber 148decreases, and the rolling diaphragm portion or dependent region 164increases in depth (i.e. moves towards base 170 of post 162). Theballoon-like bladder's folded under outer surface 172 may be maintainedin contact with the post 162 by the pressure in the bladder. As shown inFIG. 3B, the bladder 142 may eventually contact the reduced diametersection found in region 166 of post 162. As noted above, the effectivearea of the “piston” here resisting further displacement forces (thepost 162 in FIGS. 3A-3B) is less when the curved region 164 of thebladder is positioned opposite a smaller diameter post region 166 (FIG.3B) than when it is positioned opposite a larger diameter post region160 (FIG. 3A). In the illustrated embodiment, once the curved region 164of the bladder reaches the narrower post beginning at region 168, ittakes less force to push the bladder further down onto the post, becausethe pressure in the device is available over a smaller area. Thus, asthe bladder is pushed downward onto a tapered post, the resistance tomovement further decreases. As shown, the rolling diaphragm portion 164may be approximately annular in shape as it rolls along the post 162. Asthe cross-sectional area of the post 162 decreases, the inside diameterof the annular shaped rolling diaphragm portion 164 may also decrease asit may be pulled inwardly to follow the contour of the post 162.

This is in contrast to a conventional spring mattress or sealed fluidbladder mattress where the resistance to movement would increase as thesprings or sealed bladder is compressed. It should be appreciated thatthe decrease or reduction in slope of the force versus displacementcurve and the effective range of such a decrease is dependent on theexact geometry of the posts with respect to height, taper and/or rate ofchange of the cross-sectional area of the taper.

In the embodiment illustrated in FIGS. 3A-3B, the substantially straightor linear constant-force region 160 at the top of the post 162 isrelatively short, proportionally, in the vertical dimension incomparison to the remaining lower portion 166 of the post. In oneembodiment, for example, when the support device is a cushion forsitting, a short region of constant force may be appropriate. In anotherembodiment, such as when the support device is a mattress, a longerdistance of travel, i.e. a larger straight or linear constant-forceregion at the top of the post before the resistance begins to decrease,may be more appropriate. In this particular embodiment, the taper inregion 168 is of an “S” type, going through a curved surface from afirst constant diameter to a second constant diameter. It should beappreciated that other patterns are also contemplated, such as, but notlimited to a gradual taper, an abrupt taper or step change after aconstant diameter section, or any number of other configurations.

Moreover, the contrast in diameter between regions of the post isdepicted in the figures as a large difference to make its effects easierto visualize. In one embodiment, the post of the support device may havemore subtle tapers. For example, in one embodiment, the decrease in thecross-sectional area of the post is in the range of approximately 1% toapproximately 50%. In another embodiment, the decrease in thecross-sectional area of the post is in the range of approximately 5% toapproximately 35%, and in yet another embodiment, the decrease incross-sectional area of the post is in the range of approximately 10% toapproximately 30%. Exact ranges of taper (rate of diameter decrease), orratio between largest and smallest diameters or areas of parts of apost, may be selected based upon a particular application and/or user'smedical condition.

In the embodiment illustrated in FIGS. 3A-3B, the post includes a base170 which, as shown, tapers outwardly. Because the cross-sectional areaof the base 170 is greatly increased in comparison to other parts of thepost, a much larger force would be required to further move the bladderalong the base 170 of the post. In certain embodiments, an outwardlytapered base 170 may be provided so that the movement of the bladder 142stops once the bladder reaches the base 170. This may help to create asoft bottoming (i.e. preventing direct contact of the user's body withthe posts, and/or minimize its impact). As mentioned above, in oneembodiment, the posts 162 are inflatable, and may be held at a pressuregreater than system pressure in the bladders. As noted above, thepressure in the bladders may be less than 1 PSIG (pressure aboveatmospheric.) In this respect, any contact between the user's body andthe posts may be cushioned. It is also contemplated to include aresilient material on the top surfaces 146 of bladders and/or as part ofthe posts to further provide cushioning.

FIG. 4 illustrates three differing geometries for the post each with adistinct load-deflection curve and overall reduction in force applied tothe portion of patient adjacent the post supported by the bladderdespite increasing load applied from the top. In each embodiment, themodule (i.e. a bladder/post combination) support force is thecombination of the normal (axial) force due to the changing crosssectional area of the to post and the modulation effects of theincreasing or decreasing annular shape of the rolling diaphragm portionof the bladder.

FIGS. 5A-5C illustrates various components of one embodiment of asupport device of the invention 500, where the support device is amattress with modules 502 (i.e. bladder/post combination) in place atthe bottom frame 504. In this embodiment, the bottom frame 504 is a thinplenum which fluidly connects a plurality of bladders together. (FIG.5A). In one embodiment, the bottom frame 504 supports these modules andthe bottom frame 504 may also be inflatable to provide additionalcushioning to a user. It should be appreciated that the figure is notdrawn to scale, but, the basic configuration of the modules is shown. Inthis particular embodiment, the support device includes a cover 506,which is discussed in greater detail below. As shown in FIG. 5B, thesupport device also includes a blower in conjunction with a readilyavailable pressure pump control (FIG. 5C) interconnected in operativeassociation with the modules of FIG. 5A in a manner that would beapparent to those skilled in the art. Together these components comprisea basic support device unit according to one embodiment of the presentinvention. In one embodiment, this basic unit may operate in a staticmode (i.e., no air infusion into the bladders 508 at constantinflation). In another embodiment, this unit may operate in analternating pressure mode (i.e. air inflow/pressure changing accordingover time using the simple blower and the control unit), and in anotherembodiment, the unit may operate in a ventilation mode with constant airinfusion, for example by perforating the tops of the bladders as is donefor typical ventilation mattress. Furthermore, the surface of eachmodule top may include material including foam, gel, padding or othermaterial or combinations as desired or a patient contacting surface thatis disposable and conforming to the underlying surface retaining thepressure relieving benefits.

FIG. 6A illustrates a support device comprising a two dimensional arrayof inflated bladders having upper, load-bearing surfaces 12 which mayinitially all be inflated to have essentially the same volume and bepressurized to a first pressure P1. In one embodiment, the array issurrounded by a side frame (not illustrated) to maintain the bladders inposition. In such embodiments, the side frame will typically beconnected to a bottom frame such as bottom frame 28 of FIG. 1 or bottomframe 504 of FIG. 5. Such a configuration may serve to create a completemattress replacement system.

If an irregular object, for example, all or a part of a human body, isapplied to the array, and the load per module exceeds pressure P1 at anypoint, then protruding sections of the object may contact surfaces 12first, and those surfaces may be the first areas to compress. As more ofthe object comes in contact with additional bladder surfaces 12 as theobject sinks into the array, the weight of the object may be distributedover a larger and larger set of surfaces 12. If the pressure P1 is abovea certain threshold, then at some point, enough surfaces 12 may beengaged that the weight pressing on each will be below the weight neededto begin to roll the bladders along the posts, and the object willstabilize and not sink any further into the array.

In one embodiment, it may be made easier for a patient to get into/ontoa support device comprising a large array of bladders, such as amattress, by raising the internal bladder pressure to a relatively highpressure so that the mattress will remain firm while the patientinitially sits/lies on it or gets off it. Once the patient is situated,the pressure may be reduced so that the patient sinks into the mattresssufficiently to spread his weight over a larger number of bladders.

The required supporting pressure may be quite small. For example, if thearea of the patient's torso including buttocks is about 300 squareinches, and the patient weighs about 200 lbs, the required pressure tosupport the patient is about 0.67 PSI, when lying on his back orstomach. In contrast, when a patient “sinks” into a conventionalmattress, the local pressure per unit area may be considerably higher onprotruding areas such as the buttocks, and especially on the hip boneswhen lying in the side. Because in certain embodiments, at least some ofthe module bladders may be interconnected in fluid communication suchthat the pressure in each fluidically interconnected module will beessentially the same or, in other embodiments, the pressure in differentbladders may be independently set and/or controlled, protrusions on apatient's body will not be subject to increased force applied by thesupport, but can be subject to essentially the same level of force oreven a lesser level of force than surrounding areas of the patient'sbody depending on the particular shape and configuration of the postgeometry of the modules and/or the particular module pressure and theassociated force/displacement response as described previously.

Thus, aspects of the present invention are directed to a support device,such as a mattress, which may reduce the pressure on any particular areaof the body of a patient to (e.g. a protruding area) with respect to theaverage pressure exerted on overall area of contact of the mattress withthe patient's body, dictated by the patient's weight and cross-sectionalarea of contact with the support device, in a particular position,compared to conventional support devices. This effect is not readilyachieved with a conventional mattress or even a conventional air bed,each of which tends to exert higher forces per unit area on protrudingareas of a patient which leads to pressure points.

The present invention is also directed to support devices and methods ofuse which may selectively reduce the resistance to displacement in areassupporting protuberant regions of the user's body. According to oneembodiment, the support device is capable of selectively reducing theresistance in areas of protuberant regions of a user's body by reducingthe critical pressure of the bladders in a zone where the protuberantregions are located. In one embodiment, this may be done by havingmultiple zones of differing air pressure and/or multiple zones ofmodules having posts of differing geometry. For example, as shown inFIG. 6A, there can be a small zone R2 with a lower pressure in themiddle of a larger region R1 having higher pressure. As the patientsinks into the mattress support device, the bladders in zone R2 willyield first, putting more of the patient's weight on areas of the bodylying on zone R1 with higher pressure. This will likewise reduce thepressure on the selected area of the patient. The resistance to furtherpenetration of the mattress support device may be such that there may besignificantly decreased pressure supporting the protuberant areas.

In a another embodiment, a region R2 of bladder surfaces 12 may haveposts of a smaller cross sectional area than the posts in a surroundingarray region R1. When at least a portion of a user's body is positionedon the array at R2, it may sink more rapidly when pressing on moduleshaving posts of smaller area. As the user's body sinks into the array,it will begin to encounter surfaces 12 supported by posts of larger areain region R1, and may encounter greater resistance. When sufficientsurfaces are encountered, the load will be supported at some pressureuniform pressure P in the bladders in both the R1 and R2 zones (i.e. aswould be the case if the modules were interconnected in fluidcommunication with each other; however, in the R2 zone, the modules withposts of lesser cross-sectional area will not require as much forceapplied by the patient areas above and supported by such modules tocreate displacement, and so in that region of the body contacting regionR2, the force applied to the body during movement will be less,essentially according to the ratio of the cross-sectional areas of theposts in region R2 to those in region R1. At equilibrium, the pressurewill be the same on all of the body's surface; however, during anysubsequent motion, there will be less pressure applied to the area ofthe body that is positioned over region R2.

One embodiment of the present invention includes a support device in theform of cushion, mattress or other support containing an array ofbladders supported on an array of posts. A cushion support device mayhave at least one region similar to R2 in which the fluid pressuresupplied to the bladders in the region, for example a region contactinga particular part of the body, is less than that supplied to bladders ina surrounding area. In particular, pressure on a region of the body maybe lessened during contact or motion when the body region is in contactwith region R2, while higher pressure may be experienced by the body ina contiguous region or regions R1. Such a device may be useful intreating, for example, a broken coccyx, or in curing a pressure sore onthe buttocks, or in relieving pressure on an area that has been sutured,skin grafted, burned or otherwise is undergoing healing or treatment.

In certain embodiments of the invention, a region R2 of a cushionsupport device has an array of bladders on posts characterized in thatthe posts in the region R2 have a smaller diameter than posts in asurrounding region R1. This may reduce the required yield pressure fordisplacement the bladders in region R2, so that the weight of the bodyis borne preferentially by the bladders in the surrounding region R1.

In another embodiment, a region R2 has both a lower pressure, andsmaller diameter posts, in comparison to a surrounding region R1,combining the effects of the previous embodiments.

In any embodiment of the above types, valve arrangements or otherpressure/flow control arrangements capable of isolating individualbladders/post modules or zones of bladders and posts, for examplesimilar to regions R2 as shown in FIG. 6, may be used to vary pressureto create a desirable pattern of resilience and resistance todisplacement over the overall area of the support device and/or tofacilitate moving a patient along the surface of a mattress or otherdevice. Local pressure variation may also be implemented on a programmedbasis to help stimulate healing of a lesion. For example, selectedregions may have their pressures changed over timescales of seconds,minutes or hours, to improve local blood flow. In a post and bladdersystem according to the present invention, such pulsations may reducethe pressure on the affected areas when the system pressure istransiently reduced. Local pressure regulation may also be employed fordevices according to the invention configured for treating regions of apatient body not on the trunk of the body, such as heels or elbows,where pressure can be adjusted to be locally lower, e.g. to simulate asensation of “weightlessness.”. For embodiments in which the bladdersmay by directly connected to each other, any such connection mayadvantageously provide excess surface/material of connection toaccommodate significant differences in bladder heights while preventingtension from arising between adjacent bladders, or within coveringmaterials attached to the top surfaces of the bladders due to theinterconnection. It is also contemplated that pressure/flow controlarrangements may be configured to inflate and/or deflate certain rowsand/or columns of the support device in various patterns to helpreposition or rotate the patient.

FIG. 6B illustrates another embodiment in which any of theabove-described support device module characteristics may be selectivelyincorporated into any array of existing beds, systems or other surfacescomprised of all available materials such as foam, springs, fluid filledbladders, air filled bladders, gel materials, alternating pressure andventilation systems. Discrete zones of actuated and/or programmedmodules may be beneficial in conjunction with some existing systems asillustrated.

FIGS. 7A-7C illustrate how differing regions of a mattress supportdevice 700 coupled with an air pressure controller and air pump (notillustrated), may for example be used as a hospital bed (FIG. 7C). FIG.7B illustrates a hand held Personal Digital Assistant (or in otherembodiments a personal computer or other controller or computing device)which may be configured to interface with control hardware of thesupport device and programmed/configured to monitor, control and/orreport the air flow and pressure and/or other parameters relevant tooperation of the support device, for example as needed to optimize thepressure reduction therapy for the patient.

FIGS. 8A and 8B illustrate an exterior view (FIG. 8A) and a crosssectional view (FIG. 8B) of another embodiment of a bladder 40 of thepresent invention. In this particular embodiment, the profile of the topsurface 42 of bladder 40 is domed. It should be appreciated that inother embodiments, the bladder 40 may be generally square, hexagonal,round or elliptical, as the present invention is not so limited. Itshould also be recognized that the outer shape of the bladder 40 maychange depending upon the amount and pressure of fluid within thebladder. In one embodiment, the bladders are shaped and arranged tominimize any space between adjacent bladders. The side wall 46 may havea uniform thickness, which may, for example, be about 0.03 inch (ca. 0.7mm) In another embodiment, the thickness may range from less than 0.01inch to over 0.05 inch. The selected thickness may depend on the tensileproperties of the fluid-impermeable material used for the bladders, onthe desired maximum system pressure, and on the anticipated lifetime ofthe device, particularly if parts are disposable. In addition, all orpart of the bladder may have flocked, textile, or other coatings forpatient contact, which may be thicker than the fluid-impermeablematerial of the bladders. The bladders may also be reinforced.

In one embodiment, the bladder 40 may have a cross-sectional width 44 ofabout 2 inches (ca. 50 mm), so that 800 bladders in an array of 20×40bladders would have a surface about 40 inches wide and 80 inches long,similar to a conventional mattress. Other sizes of bladders are alsocontemplated, and different sizes of bladders may be placed in the samearray. In one mounting system, the bladder 40 may be formed to taper toa cross section width 48 at its mouth that is smaller than the width 44of the main portion of the bladder, and may have a collar 50 with a rim52 for mounting to a post. For example, when width 44 is about 2 inches,mouth width 48 may be about 1.6 inches, and collar 50 might have athickness 52 of about 0.1 inches (ca. 2.5 mm).

FIGS. 9A-9F illustrate two methods of coupling a bladder 60 to a post 70to obtain a smooth rolling motion of the bladder onto the post via acurved region 64. A bladder 60 with a neck region 62 is shown in crosssection in FIG. 9A. The neck may first be inverted, as shown in FIG. 9B,creating a curved region 64. A post 70 is provided (FIG. 9C), and thebladder may be slid onto post 70 and sealed with a layer of adhesive 66,as shown in FIG. 9D. The adhesive may, for example, be applied to post70 before its insertion into neck region 62.

FIG. 9E-9H illustrate installation of a bladder with a collar, similarto FIGS. 8A and 8B. The bladder 61 has a neck 63 and collar 65 (FIG.9E), and is inverted (FIG. 9F) forming a curved region 67. The post 71has a notch 73 into which collar 65 fits. When the post 71 is insertedinto the neck region 63, the collar 65 snaps into the notch 73. For lowpressures (e.g., 1-10 PSI), this method of sealing may to providesufficient sealing without the use of adhesives. However, adhesives maybe applied as in FIG. 9D.

FIGS. 10A-10B illustrate a cross-section of two bladders having a typeof connecting surfaces 180 between adjacent bladders. The connectingsurfaces 180, and the tops 182 of the bladders may have coatings placedthereon for patient comfort. The entire connection surface may be madein the form of a sheet which is adhered to the bladders of an array, anddrapes between then. The arrows shown in FIG. 10A depict possible airflow which may be in an embodiment with ventilation on top of or on anysurface of the bladder or the patient contacting surface which may helpreduce moisture on the patient contacting surface.

FIG. 11 illustrates the movement of the connecting surfaces when thereis a large disparity in the degree to which the top surfaces of adjacentbladders are differentially depressed. A covering material with afabric, weave and/or stretch may allow the translation of the reducedpressure effect. In some embodiments, the use of a cover may reduceand/or eliminate the reduced pressure effect. A covering as shown inFIG. 11 that allows for independent movement of elements or small groupsof elements according to the anatomy may be fashioned from availablematerials in the specialty fabric industry.

Another embodiment of a support device according to the presentinvention is illustrated in FIG. 12. Some of the above describedembodiments include individual bladders coupled to posts, and a topcovering layer may be adhered to the bladders. Some of the abovedescribed embodiments also include fluid being supplied to the bladdersthrough a channel within the posts.

In the embodiment shown in FIG. 12, the upper surface 211 of the supportdevice, such as a cushion or bed, may be removable and disposable, whichmay simplify sanitation. FIG. 12 illustrates a cross-sectional view of asupport device with a removable surface 280. In particular, theembodiment shown in FIG. 12 includes at least one bladder 210, and onlya single bladder 210 in certain embodiments, capable of containing afluid. As shown, the bladder of this embodiment includes at least onefluid inlet 212 and an upper surface 214.

The at least one bladder 210 is positioned over a plurality of posts230. Each post may have an upper contacting region 234 or 236 wherecontact with the bladder is to made. In some embodiments, the posts mayalso have a taper 240 or a discrete indentation 242, or other form oftapering, to give the above-described decrease in resistance upon travelto discrete areas of the bladder positioned adjacent to and supported bythe posts. As noted above, a post of the invention may have an outward(increasing) taper or step 246 at the bottom to provide a gradual stopor foot when depressed too far. In some embodiments, the posts may beinflatable through an inflation lumen 250 and connector 254. In anotherembodiment, the posts may be solid, and may optionally be made from aresilient material and/or with resilient material attached to the topsurface 234 or 236 of the post. In this embodiment, the posts may befixed to a supporting frame 260.

In this particular embodiment, the at least one bladder 210 includes aplurality of regions 216 and 217 adjacent each post. As shown, bladderregion 217 is depressed in height by a weight 219. Each inflatablebladder region may include a flexible sidewall 218 and a post-contactingregion 220, which may have a preformed shape, such as the dome shape ofcontact region 222 of bladder 216 or the flat contact region 223 ofbladder 217.

Flexible guides 290 may be provided to orient the bladders. In thisparticular illustrative embodiment, the guides 290 are essentiallycylindrically shaped and may, for example, be made of elastic cording orfabric. The guides 290 may encircle each post to help orient the bladderportions 216, 217, etc to the posts 230. It should be appreciated thatin some embodiments the guides may be shaped differently, such as, butnot limited to, square shaped, triangular shaped, etc. Connecting region280 of at least one 210 may act similar to the connector 30 of FIG. 1,providing fluid communication between bladder regions 216 and 217.

The upper portion 211 may be disposable and may be installed row by row,for example, and the upper portion 211 may be coupled to selectedportions of the bladder 210 with a reversible contact adhesive. In oneembodiment, the upper portion 211 may be removably coupled to thebladder with a fastener such as VELCRO®. Pressure may be put into theupper portion 211 to partially inflate the bladder which may assist inlocking the bladder in an oriented state on the posts. After correctionof any mismatches and re-inflation, the support device may be ready tobe used. Bladder region 216 (left) shows the state with no appliedweight, and bladder region 217 (right) shows the effect of weight 219being applied. In this embodiment, the bladder region in theweight-bearing region is still in the linear zone and does not yet havethe low resistance region 242 in operation. The arrows in FIG. 12 depictoptional air flow for ventilation on top of or one any surface of thebladder.

Supporting Data for the Invention

According to certain aspects of the present invention, a profile ofpressure reduction as a function of compression is evident in contrastto similar profiles for foam-based pressure relieving mattresses.Supporting data for several embodiments are presented below and comparedwith data for a foam mattress.

In particular, FIG. 13A illustrates measurements on a single module ofthe invention at four internal pressures wherein a known load is placedon the top of the module compressing the bladder down along the lengthof the post. The internal pressures represented are: Curve A, 20 mm Hg(diamonds); Curve B, 30 mm Hg (squares); Curve C, 40 mm Hg (triangles);Curve D, 50 mm Hg (crosses). The dimensions of the support device moduleused in this particular test are illustrated in FIGS. 13B-13C. Fivesupport device modules with dimensions as in FIGS. 13B-13C were testedin load-deflection at the nominal inflation pressure of 30 mm-Hg andwere found to have essentially identical results. One of the modules wasload-deflection tested at four pressures (20, 30, 40 and partially 50mm-Hg). The load measurements were made on a Chatillon Force MeasurementInstrument recently calibrated and certified. Air was pumped into themodule via tubing connections to outlet 152 (FIG. 3) using a small airpump for home use at 0.03 gal/min, 150 mm-Hg max. 115VAC. Asphygmomanometer gauge 0-200 mm-Hg and a standard forward pressureregulator 0-150 psi were used to control the internal pressure and tomaintain positive pressure. The rate of change in deflection ordisplacement was set at 0.4″ per minute to minimize transition effects.Measurements were recorded of both load and deflection at +/−0.1″intervals over the entire stroke of the module. Zero setting wasachieved by adjusting starting position with a load of 0.01″ on themodule top. The surface area of the module top is 4 in sq.

According to the data in FIG. 13A, the trend for all the pressuresmeasured show an initial increase in load with deflection forapproximately 0.25″ followed by a reduction in load to approximately0.6″. The curves for all pressures remain reduced relative to theinitial peak up to approximately 2″ and end with increasing load towardthe last 0.6″ of the stroke. The higher the internal pressure the largerthe initial peak, as seen in Curve D, for example, consistent with themechanism as described earlier. The first portion of the strokecompresses the air in the diaphragm which must overcome resistance torolling over the lip of the base post accounting for the initial peakand the increasing peak as a function of internal pressure.

Subsequently, as the diaphragm rolls over the top of the post andengages the reduced diameter region of the post, a reduction in slope ofthe load is seen. As the post diameter increases towards the base of thepost the load correspondingly increases till the diaphragm materialencounters the actual base unit and is bottomed out. The behavior asdescribed is consistent with observation and mechanism as detailed inprevious sections.

FIG. 13D illustrates the calculated contact pressure based on the loaddeflection data presented in FIG. 13A using a supporting surface area ofapproximately 2 in² representing the top of the support device module inthis case. The calculated contact pressure for all curves is below 32 mmHg as shown for Curve A, 40 mm Hg (upper curve), Curve B, 30 mm Hg(middle curve) and for Curve C, 20 mm Hg (lower curve).

The load deflection profiles for some embodiments of the presentinvention described herein in comparison to that for a foam and watermattress is shown in FIG. 14. The data for the foam, Curve B and watermattress, Curve A, are adapted from Small, C. F. (1980) Flat CircularPunch Testing of Clinical Support Devices IMechE 9 (1): 1-15, andmeasured in a similar fashion with similar surface area of 5 cm diameterplate which compares with the 4 square inch surface of the supportdevice module tested. According to the data it can be readily seen fromcurves A and B that the foam and water mattress have typical curvesreflecting increasing load with deflection characterized by steeplyincreasing positive slopes attaining up to 20 lbs pressure over acompression of about 2″. In comparison with the foam mattress theload-deflection curve for one embodiment of the present invention, CurveC, is flat and slightly decreasing in slope in a portion of the stroke.Based on the comparison of published data and data for the module of theinvention measured directly in the laboratory, certain embodiments ofthe present invention described herein may offer reductions in load andtherefore pressure of approximately 38% and 75% at deflections of 1″ and2″, respectively, compared to a to typical high density foam mattress.The reductions in load observed for a single support device module willalso apply to arrays with a plurality of modules and offer pressurereduction in magnitude and in a manner not currently available to thepressure reducing mattress industry or to those suffering from pressurerelated ulcers.

While several embodiments of the invention have been described andillustrated herein, those of ordinary skill in the art will readilyenvision a variety of other means and structures for performing thefunctions and/or obtaining the results or advantages described herein,and each of such variations, modifications and improvements is deemed tobe within the scope of the present invention. More generally, thoseskilled in the art would readily appreciate that all parameters,dimensions, materials, and configurations described herein are meant tobe exemplary and that actual parameters, dimensions, materials, andconfigurations will depend upon specific applications for which theteachings of the present invention are used. Those skilled in the artwill recognize, or be able to ascertain using no more than routineexperimentation, many equivalents to the specific embodiments of theinvention described herein. It is, therefore, to be understood that theforegoing embodiments are presented by way of example only and that,within the scope of the appended claims and equivalents thereto, theinvention may be practiced otherwise than as specifically described. Thepresent invention is directed to each individual feature, system,material and/or method described herein. In addition, any combination oftwo or more such features, systems, materials and/or methods, providedthat such features, systems, materials and/or methods are not mutuallyinconsistent, is included within the scope of the present invention. Alldefinitions, as defined and used herein, should be understood to controlover dictionary definitions, definitions or usage in documentsincorporated by reference, and/or ordinary meanings of the definedterms.

In the claims (as well as in the specification above), all transitionalphrases or phrases of inclusion, such as “comprising,” “including,”“carrying,” “having,” “containing,” “composed of,” “made of,” “formedof,” “involving” and the like shall be interpreted to be open-ended,i.e. to mean “including but not limited to” and, therefore, encompassingthe items listed thereafter and equivalents thereof as well asadditional items. Only the transitional phrases or phrases of inclusion“consisting of” and “consisting essentially of” are to be interpreted asclosed or semi-closed phrases, respectively. The indefinite articles “a”and “ an, ” as used herein in the specification and in the claims,unless clearly indicated to the contrary, should be understood to mean“at least one.”

What is claimed is:
 1. A device for supporting at least a portion of auser's body, the device comprising: a plurality of bladders capable ofcontaining a fluid, the plurality of bladders including at least a firstbladder and a second bladder; and a plurality of posts adjacent to andsupporting the plurality of bladders, such that at least one post ispositioned adjacent to and supports each of the plurality of bladders,the plurality of posts including at least a first post and a secondpost, with the first post positioned adjacent to and supporting thefirst bladder and the second post positioned adjacent to and supportingthe second bladder, wherein the first and second bladders each forms arolling diaphragm portion with the first and second posts, respectively,such that when a force is applied to the first bladder, the rollingdiaphragm portion of the first bladder rolls along the first postdecreasing the volume of the first bladder, and when a force is appliedto the second bladder, the rolling diaphragm portion of the secondbladder rolls along the second post decreasing the volume of the secondbladder. 2.-15. (canceled)
 16. A device for supporting at least aportion of a user's body, the device comprising: at least one bladdercapable of containing a fluid; and a plurality of posts adjacent the atleast one bladder, the plurality of posts including at least a firstpost and a second post, wherein at least a portion of the at least onebladder forms a first and second rolling diaphragm portion with thefirst and second posts, respectively, such that when a force is appliedto the at least one bladder at a location adjacent the first post, thefirst rolling diaphragm portion of the at least one bladder rolls alongthe first post decreasing the volume of the at least one bladder, andwhen a force is applied to the at least one bladder at a locationadjacent the second post, the second rolling diaphragm of the at leastone bladder rolls along the second post decreasing the volume of the atleast one bladder. 17.-27. (canceled)
 28. A device for supporting atleast a portion of a user's body, the device comprising: a bladdercapable of containing a fluid; a post adjacent the bladder, wherein thebladder forms a rolling diaphragm portion with the post such that when aforce is applied to the bladder, the rolling diaphragm portion of thebladder rolls along the post decreasing the volume of the bladder; andwherein the post includes at least one region having a reducedcross-sectional area in comparison to an adjacent region of the postsuch that the resistance of the rolling diaphragm portion of the bladderto rolling movement along the post due to the applied force decreases asthe bladder rolls along the at least one region having the reducedcross-sectional area. 29.-34. (canceled)